510(k) Report

Devices descending from K192399

3 later devices reach Infinity Angioplasty Balloon Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K214038Oscar Peripheral Multifunctional Catheter systemBiotronik, Inc.20222—
+2K241711Oscar Peripheral Multifunctional Catheter systemBiotronik, Inc.20241—
+3K250706Passeo-35 Xeo Peripheral Dilatation Catheter; Passeo-18 Peripheral Dilatation Catheters…Biotronik, Inc.20250—